Designed to draw blood from in-dwelling peripheral IV catheters and eliminate the need for multiple needle-sticks, PIVO is being implemented at University Hospitals Cleveland Medical Center for inpatient blood draws. “UH is rolling out PIVO in 20- and 22-gauge sizes,” which are commonly used for most patients, including some toddlers, Velano Vascular chief executive and co-founder Eric Stone told MD+DI. The company had won 510(k) clearance from FDA for an updated design last year.

“As an institution, we continually look for innovative new technologies that improve the delivery and quality of care we provide,” stated UH Cleveland Medical Center President Daniel I. Simon, MD, in a news release. “As caregivers, we strive to serve our patients in the most humane and personal way possible. This new procedure makes it possible for us to do both, eliminating the pain and anxiety associated with blood collection while advancing our own high standards and practices.”

When attached to a peripheral IV catheter, another small catheter, situated inside PIVO, advances through the IV catheter into the patient’s vein and draws blood into a syringe or an evacuated tube attached to the other end of PIVO, explained Stone. The process takes between 30 to 120 seconds. After the blood draw, practitioners retract PIVO’s catheter from the vein and disconnect the device from the peripheral IV catheter, which can then return to infusion.

“No other technology that we are aware of can draw a lab-quality specimen consistently from in-dwelling catheters in place beyond a day,” Stone told MD+DI. “As soon as an IV softens up from blood exposure and at body temperature, it loses important mechanical properties necessary for drawing blood.” PIVO is able to manage the loss of those properties and accomplish a successful blood draw, he said.

“PVIO is designed such that it doesn’t lead to a negative effect or consequence for the IV; studies have shown that as long as an IV is in good condition, PIVO is effective for drawing blood,” he added.

Use of PIVO could also help hospitals shift away from accessing central lines for blood draws, which could be a potential source of central line associated bloodstream infection (CLABSI). “PIVO offers an alternative to accessing central lines,” Stone said. “CLABSI can be life threatening, and it is a fineable event for hospitals” from CMS.

UH found the technology can extract high-quality blood samples from the vein, eliminating the need for multiple needle-sticks, it was reported. “Our evaluation and collaboration proved that PIVO delivers high-quality blood draws in an elegant manner that enhances the patient-practitioner relationship, reduces rejected blood samples, and provides an alternative to accessing central lines for blood collection,” stated Cheryl O’Malley, Vice President Patient Care Services and Nursing, UH Cleveland Medical Center, in the release. “We are excited to bring this procedure and technology to our entire academic hospital, especially for our most vulnerable patients like those at UH Rainbow Babies & Children’s.” O'Malley presented the results of a study in a poster presentation, "Reducing Risks of Central Line Access and Viability of Moving to the Periphery." Among the results presented were those showing that PIVO successfully collected a sample 81% of the draws as well as patient feedback that showed a strong preference for PIVO over needles.

Stone said the technology allows blood to be drawn humanely from patients. “We see cases of children sleeping through blood draws—it is remarkable, and it is heartwarming,” he said.

Velano continues to “work tirelessly on developing a PIVO solution for high-risk patients, such as for very small children and infants,” he said, indicating that it would be a 24-gauge device. “It is not available yet, but we are seeing promising results.” The company had won a grant a few years ago for such development.

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest.Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.